GIT-LCA Glove Integrity TesterFunctional Test Protocol
Software Version Applicable to this document:
PLC file name: GIT-LCA – PLC v2.1
OIT file name: GIT-LCA – OIT v2.1
Dynamic Design Pharma, Inc.
23332 Madero Road, Suite J
Mission Viejo, California 92691
June 8, 2007
GIT-LCA Glove Integrity Tester Page 2
Functional Test Protocol Date: June 8, 2007
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TABLE OF CONTENTS
1. PURPOSE ............................................................................................................................................ 3
2. SYSTEM IDENTIFICATION............................................................................................................... 3
3. EXECUTION INSTRUCTIONS AND RESPONSIBILITIES .......................................................... 3
4. REFERENCES..................................................................................................................................... 3
5. TEST CASES ....................................................................................................................................... 5
6. PROTOCOL COMPLETION STATEMENT/SYSTEM RELEASE............................................. 28
GIT-LCA Glove Integrity Tester Page 3
Functional Test Protocol Date: June 8, 2007
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1. PURPOSE
The purpose of this document is to test the functionality of the control system, electrical andsoftware, of the GIT-LCA Serial Number 001 glove Integrity tester. This protocol prepares thesystem for functional portion of the Factory Acceptance Testing.
Note: This document is not a software validation protocol. The software, PLC v1.0 and OIT v1.0,has been previously tested under Software Verification Protocol dated August 22, 2006 andexecuted on September 10, 2006. The current software version, PLC v2.1 and OIT v2.1, includemodifications that were documented under protocols SC-101 4-3-07 and SC-102 6-7-07.
The functional areas covered by this protocol are:
1) Analog Inputs and Outputs
2) Digital Inputs and Outputs
3) A/B channel selection
4) Security – Parameters Access Interlock
5) Security – Calibration Access Interlock
6) Leak Test Process
7) System Test Function
8) In-Situ Calibration Normal Sequence
9) Printing functions
Document any discrepancies in the “test notes” page of this protocol. Print additional copies, ifnecessary.
2. SYSTEM IDENTIFICATION
GIT-LCA glove integrity tester.
Ergoclean Gloveport interface.
3. EXECUTION INSTRUCTIONS AND RESPONSIBILITIES
The execution of this protocol will be conducted by a Quality Assurance or Engineeringrepresentative of Dynamic Design Pharma.
4. REFERENCES
GIT-LCA Glove Integrity Tester Specification
GIT-LCA Glove Integrity Tester Page 4
Functional Test Protocol Date: June 8, 2007
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GIT-LCA Glove Integrity Tester Functional and Design Specification.
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5. TEST CASES
5.1. TEST # 1 – ANALOG INPUT/OUTPUT
Test Purpose: This test confirms that the analog inputs and outputs are correctly connected and scaled.
Test Tools: Laptop connected to the PLC in monitor mode and voltmeter. System Test mode of operation.
Test Set up: Gloveport interface connected to the A port.
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1
Adjust the Up/Downarrows until the value of%AQ012 = 8000.Measure the voltage atthe %AQ12 terminal.Note the flow rate valuedisplay on the OIT.
The voltage at %AQ012 terminal is2.5VDC.
The flow rate value on the OITdisplay is 50 +/-1 Sccm.
Pass
Fail
2
Adjust the Up/Downarrows until the flow ratevalue displayed on theOIT is 50 Sccm. Note thevalue of %AI019.
%AI019 value is 8,000. Pass
Fail
3
Adjust the flow rate toachieve a pressurereading on the OIT of1,875 pa. Note the valueof %AI018.
%AI018 value is 16,000. Pass
Fail
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5.2. TEST # 2 – DIGITAL INPUT/OUTPUT
Test Purpose: This test confirms that the digital inputs and outputs are correctly connected.
Test Tools: Laptop connected to the PLC in monitor mode.
Test Set up: None.
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1
Actuate the Key Lock tothe Locked position andUnlocked position.Confirm On/Off statusfrom LEDs on PLC.
%I1 input is OFF in the Lockedposition.
%I1 input is ON in the Unlockedposition.
Pass
Fail
2 Force output %Q002 ONand then OFF.
The Inflate (K1) valve actuates (isenergized) when the output is ON.
Pass
Fail
3 Force output %Q003 ONand then OFF.
The Deflate (K2) valve actuates (isenergized) when the output is ON.
Pass
Fail
4 Force output %Q004 ONand then OFF.
The Vacuum/Pressure (K3), Flowdirection (K4) and Pressure Polarity(K5) valves actuate (are energized)when the output is ON.
Pass
Fail
5 Force output %Q006 ONand then OFF.
The Beeper comes on when theoutput is ON.
Pass
Fail
6 Force output %Q007 ONand then OFF.
The Pressure Inlet (K6) valveactuates (is energized) when theoutput is ON.
Pass
Fail
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StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
7 Force output %Q008 ONand then OFF.
The Vacuum Outflow (K7) valveactuates (is energized) when theoutput is ON.
Pass
Fail
8 Force output %Q009 ONand then OFF.
The Channel Select – Pressure (K8)and Channel Select – Flow (K9)valve actuate (are energized) whenthe output is ON.
Pass
Fail
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5.3. TEST # 3 – A/B CHANNEL SELECTION AND POSITIVE/NEGATIVE PRESSURE MODE OF OPERATION
Test Purpose: This test covers the functionality of the A/B channels and the positive/negative pressure mode of operation. This test isconducted with the system in System Test mode.
Test Tools: Test device connected to A or B channel, as required by the test conducted
Test Set up: None
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1From Home screen,depress the System Testbutton
The System Test screen comes on. Pass
Fail
2
Select the A channel andPositive pressure mode.
Depress the High FlowPlus button
Airflow comes out of one of the Achannel connectors.
No airflow comes out of either one ofthe two B channel connectors.
Pass
Fail
3
Select the B channel andPositive pressure mode.
Depress the High FlowPlus button
Airflow comes out of one of the Bchannel connectors.
No airflow comes out of either one ofthe two A channel connectors.
Pass
Fail
4
Select the A channel andNegative pressure mode.
Depress the High FlowPlus button
Air flows into one of the A channelconnectors (vacuum).
No airflow into either B channelconnectors.
Pass
Fail
5
Select the B channel andNegative pressure mode.
Depress the High FlowPlus button
Air flows into one of the B channelconnectors (vacuum).
No air flow into either A channelconnectors.
Pass
Fail
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 9
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5.4. TEST # 4 – SECURITY - PARAMETERS ACCESS INTERLOCK
Test Purpose: This test covers the functionality of the Parameters Access Interlock function.
Test Tools: None
Test Set up: No specific system set up is necessary.
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1
Place the keylock in the“locked” position.
From Home screen,depress the Parametersbutton
Access Denied popup screen comeson.
Parameters printing icon is presentand is functional.
When “Exit” is pressed, the Homescreen returns active.
Pass
Fail
2
Place the keylock in the“unlocked” position.
From Home screen,depress the Parametersbutton
The Entry Confirmation popupscreen comes on. Pass
Fail
3 Depress the “No” button. The OIT displays the Home screen Pass
Fail
4 Depress the “Yes”button.
The OIT displays the ParameterManagement screen.
Pass
Fail
5Remove the key from thekeylock while in the“unlocked” position
The key cannot be removed from thekeylock
Pass
Fail
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5.5. TEST # 5 – SECURITY - CALIBRATION ACCESS INTERLOCK
Test Purpose: This test covers the functionality of the Calibration Access Interlock function.
Test Tools: None
Test Set up: No specific system set up is necessary.
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1
Place the keylock in the“locked” position.
From Home screen,depress the Calibrationbutton
Access Denied popup screen comeson.
When “Exit” is pressed, the Homescreen returns active.
Pass
Fail
2
Place the keylock in the“unlocked” position.
From Home screen,depress the Calibrationbutton
The Entry Confirmation popupscreen comes on. Pass
Fail
3 Depress the “No” button. The OIT displays the Home screen Pass
Fail
4 Depress the “Yes”button.
The OIT displays the SystemCalibration screen.
Pass
Fail
5Remove the key from thekeylock while in the“unlocked” position
The key cannot be removed from thekeylock
Pass
Fail
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5.6. TEST # 6 – LEAK TEST PROCESS - PASSING TEST
Test Purpose: This test covers the functionality of the Leak Test Conclusion and test outcome determination.
Test Tools: Test device connected to A channel ports.
Test Set up: Program the A channel system parameters as follows:
5.6.1. Maximum pressure: 3500 pa5.6.2. Over-Pressure: 1100 pa.5.6.3. Threshold Pressure: 1000 pa.5.6.4. Maximum Flow: 60 Sccm5.6.5. Minimum Flow: 40 Sccm5.6.6. Inflate time: 60 Sec.5.6.7. Stabilization time: 30 Sec.5.6.8. Leak Test time: 60 Sec.5.6.9. Mode of operation: Positive Pressure5.6.10. Pressure Trending: Off
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments/ Exception
Report #
1
Conduct a full cycle leaktest. Set up thegloveport interfacesimulator for a passingtest.
1. The OIT switches to the CycleResults screen
Pass
Fail
2
Take note of thefollowing:
1. The end pressure
2. The end flow
3. The total cycle time
1. The end pressure matches thevalue seen at the end of the testcycle
2. The flow matches the value seen atthe end of the test cycle
3. The time display matches the totaltime of the test cycle
Pass
Fail
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 12
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StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments/ Exception
Report #
3 Cycle Results screendetails:
1. The channel display is: A
2. The test method display is “cycletime out”
Pass
Fail
4End pressure > 1000pa
(passing test)
1. The cycle result display is: PASS
2. The cycle results display is green incolor.
Pass
Fail
5
1. Depress the printericon
2. Enter “10” as theglove ID
3. Depress “Print”button
1. A print out is generated with thecorrect date
2. Glove ID matches the valueentered
3. Test outcome is: PASS
4. Active channel is: A
5. The end pressure, end flow andtotal cycle time values match thepreviously recorded values
6. Test method: Cycle Time Out
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5.7. TEST # 7 – LEAK TEST PROCESS - FAILING TEST
Test Purpose: This test covers the functionality of the Leak Test Conclusion and test outcome determination.
Test Tools: Test device connected to A channel ports.
Test Set up: Program the A channel system parameters as follows:
5.7.1. Maximum pressure: 3500 pa5.7.2. Over-Pressure: 1100 pa.5.7.3. Threshold Pressure: 1000 pa.5.7.4. Maximum Flow: 60 Sccm5.7.5. Minimum Flow: 40 Sccm5.7.6. Inflate time: 60 Sec.5.7.7. Stabilization time: 30 Sec.5.7.8. Leak Test time: 60 Sec.5.7.9. Mode of operation: Positive Pressure5.7.10. Pressure Trending: Off
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments/ Exception
Report #
1
Conduct a full cycle leaktest. Set up thegloveport interfacesimulator for a passingtest.
2. The OIT switches to the CycleResults screen
Pass
Fail
2
Take note of thefollowing:
1. The end pressure
2. The end flow
3. The total cycle time
1. The end pressure matches thevalue seen at the end of the testcycle
2. The flow matches the value seen atthe end of the test cycle
3. The time display matches the totaltime of the test cycle
Pass
Fail
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 14
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StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments/ Exception
Report #
3 Cycle Results screendetails:
1. The channel display is: A
2. The test method display is “cycletime out”
Pass
Fail
4End pressure < 1000pa
(failing test)
1. The cycle result display is: FAIL
2. The cycle results display is red incolor.
Pass
Fail
5
1. Depress the printericon
2. Enter “10” as theglove ID
3. Depress “Print”button
1. A print out is generated with thecorrect date
2. Glove ID matches the valueentered
3. Test outcome is: FAIL
4. Active channel is: A
5. The end pressure, end flow andtotal cycle time values match thepreviously recorded values
6. Test method: Cycle Time Out
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 15
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5.8. TEST # 8 – LEAK TEST PROCESS WITH PRESSURE TRENDING (PASSING)
Test Purpose: This test covers the functionality of the Leak Test process with pressure trending.
Test Tools: Test device connected to A channel ports.
Test Set up: Program the A channel system parameters as follows:
5.8.1. Maximum pressure: 3500 pa5.8.2. Over-Pressure: 1100 pa.5.8.3. Threshold Pressure: 1000 pa.5.8.4. Maximum Flow: 60 Sccm5.8.5. Minimum Flow: 40 Sccm5.8.6. Inflate time: 60 Sec.5.8.7. Stabilization time: 30 Sec.5.8.8. Leak Test time: 180 Sec.5.8.9. Time before sampling: 30 Sec.5.8.10. Time between samples: 5 Sec.5.8.11. Number of samples: 105.8.12. Mode of operation: Positive Pressure5.8.13. Pressure Trending: On
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1From Home screen,depress the CycleControl button
The Cycle Control screen comes on. Pass
Fail
2 If necessary, change theactive channel to A.
If the active channel display iscurrently B, it will change to A.
Pass
Fail
3
If necessary, adjust theflow arrow keys until theflow rate is approximately50 Sccm,
The flow rate will change up or downaccording to the arrow key that isdepressed.
Pass
Fail
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StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
4Depress the Start/Stopbutton to initiate thecycle.
1. The Pressure trendingindicator is: ON
2. The Pos. and Neg. value = 0
3. The Inflate phase takes place
4. The Stabilization phase takesplace
5. The phase count down timercounts down from 180
6. After a 30 second delay fromthe end of stabilization, thesystem enters the Leak Testphase
7. The OIT screen displays theTime Delay message.
Pass
Fail
5
The Leak test phaseprogresses. Pressure is> 1000 and steadilyclimbing.
1. Every 5 seconds, the POScount increases by 1
2. When the POS count reaches10, the Leak test phaseconcludes.
Pass
Fail
6 Allow the Leak Test cycleto conclude
1. The OIT switches to the CycleResults screen
Pass
Fail
7
Take note of thefollowing:
1. The end pressure
2. The end flow
3. The total cycle time
1. The end pressure matches thevalue seen at the end of thetest cycle
2. The flow matches the valueseen at the end of the testcycle
2. The time display matches thetotal time of the test cycle
Pass
Fail
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StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
8 Cycle Results screen1. The channel display is: A
2. The test method display is“pressure trend”
Pass
Fail
9End pressure > 1000paand positive trenddetected
1. The cycle result display is:PASS
2. The cycle results display isgreen in color.
Pass
Fail
10
1. Depress the printericon
2. Enter “10” as theglove ID
3. Depress “Print”button
1. A print out is generated withthe correct date
2. Glove ID matches the valueentered
3. Test outcome is: PASS
4. Active channel is: A
5. The end pressure, end flowand total cycle time valuesmatch the previously recordedvalues
6. Test method: Pressure Trend
Pass
Fail
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5.9. TEST # 9 – LEAK TEST PROCESS WITH PRESSURE TRENDING (FAILING)
Test Purpose: This test covers the functionality of the Leak Test process with pressure trending.
Test Tools: Test device connected to A channel ports.
Test Set up: Program the A channel system parameters same as Test #24
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1From Home screen,depress the CycleControl button
The Cycle Control screen comes on. Pass
Fail
2 If necessary, change theactive channel to A.
If the active channel display iscurrently B, it will change to A.
Pass
Fail
3
If necessary, adjust theflow arrow keys until theflow rate is approximately50 Sccm,
The flow rate will change up or downaccording to the arrow key that isdepressed.
Pass
Fail
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StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
4Depress the Start/Stopbutton to initiate thecycle.
1. The Pressure trending indicatoris: ON
2. The Pos. and Neg. value = 0
3. The Inflate phase takes place
4. The Stabilization phase takesplace
5. The phase count down timercounts down from 180.
6. After 30 seconds delay fromthe end of stabilization, thesystem enters the Leak Testphase.
7. The OIT Status Displaydisplays “Time Delay”.
Pass
Fail
5
The Leak test phaseprogresses. Pressure is< 1000 and steadilydropping.
1. Every 5 seconds, the NEG.count increases by 1
2. When the NEG. count reaches10, the Leak test phaseconcludes.
Pass
Fail
6 Allow the Leak Test cycleto conclude
1. The OIT switches to the CycleResults screen
Pass
Fail
7
Take note of thefollowing:
1. The end pressure
2. The end flow
3. The total cycletime
1. The end pressure matches thevalue seen at the end of thetest cycle
2. The flow matches the valueseen at the end of the testcycle
3. The time display matches thetotal time of the test cycle
Pass
Fail
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StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
8 Cycle Results screen1. The channel display is: A
2. The test method display is“pressure trend”
Pass
Fail
9End pressure < 1000paand negative trenddetected
1. The cycle result display is:FAIL
2. The cycle results display is redin color.
Pass
Fail
10
1. Depress the printericon
2. Enter “25” for gloveID
3. Press “Print”
1. A print out is generated withthe correct date
2. Glove ID matches the valueentered
3. Test outcome is: FAIL
4. Active channel is: A
5. The end pressure, end flowand total cycle time valuesmatch the previously recordedvalues
6. Test method: Pressure Trend
Pass
Fail
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5.10. TEST # 10 – SYSTEM TEST FUNCTION
Test Purpose: This test covers the functionality of the System Test function.
Test Tools: Test device
Test Set up: No specific system set up is necessary.
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1From Home screen,depress the System Testbutton
The System Test screen comes on. Pass
Fail
2Time Elapsed valuedisplay functionality –Counting
The value of the timer is 0 uponentry into the screen and counts upat 1 second frequency continuouslywhile the screen is active.
Pass
Fail
3Time Elapsed valuedisplay functionality –Resetting
Upon depressing the Reset buttonthe value of the Time Elapseddisplay is reset to zero. The counterimmediately resumes counting at 1second frequency.
Pass
Fail
4
Connect the gloveportsimulator to the Achannel.
Select the A channel andpositive pressure
Actuate the High FlowPlus button
The Pressure PV display reflects arapid increase in internal pressure ofthe simulator.
Pass
Fail
5 Actuate the High FlowMinus button
The Pressure PV display reflects arapid decrease in internal pressureof the simulator
Pass
Fail
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StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
6
Allow the pressure tostabilize between the1000 and 2000 Pa.
Actuate the Low FlowPlus button
The Pressure PV display reflects aslow increase in internal pressure ofthe simulator
The Low Flow display increases invalue until it reaches 100.
Pass
Fail
7 Actuate the Low FlowMinus button
The Pressure PV display reflects aslow increase in internal pressure ofthe simulator
The Low Flow display decreasesuntil it reaches 0.
Pass
Fail
8
Actuate the Low Flowbuttons to set the flowrate at approximately50Sccm.
Allow the pressure tosettle.
Make note of the currentPressure, Flow Rate andTime Elapsed andactuate the printer icon.
The “Print System Test Results”screen comes on and shows the endof test Pressure, Flow Rate andTime Elapsed and the active channel(A channel).
Pass
Fail
9 Activate the “OK” button.
1. A print out is generated withthe correct date
2. Active channel is: A
3. The end pressure, end flowand elapsed time values matchthe previously recorded values
4. System returns to the Homescreen
Pass
Fail
10Actuate the Key Lockswitch On/Off severaltimes.
Actuation of the Key Lock switch hasno impact on the System Testfunction.
Pass
Fail
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 23
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StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
11
Connect the gloveportsimulator to the Bchannel connections.
Change the activechannel selection to “B”.
Actuate the Low Flowbuttons to set the flowrate at approximately50Sccm.
Make note of the currentPressure, Flow Rate andTime Elapsed andactuate the printer icon.
The “Print System Test Results”screen comes on that shows the endof test Pressure, Flow Rate andTime Elapsed and the active channel(B channel).
Upon activation of the OK button, aprint out of the end of test valuesand the active channel (B channel) isproduced.
Pass
Fail
12
Connect the gloveportsimulator to the Achannel.
Select the A channel andpositive pressure
Actuate the High FlowPlus button
Allow the pressure toreach 3,750 pascals.
K2– Deflate (%Q3) valve actuates toprevent the pressure internal to thesimulator to increase above 3,750pa.
Pass
Fail
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 24
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5.11. TEST # 11 – IN–SITU CALIBRATION – NORMAL SEQUENCE
Test Purpose: This test covers the functionality of the In-Situ calibration process sequence.
Test Tools: Test device.
Test Set up: Test device connected to the A ports, interlock key in the “unlocked” position.
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1From Home screen,depress the Calibrationbutton
The System Calibration screencomes on.
Pass
Fail
2
Make note of the FixedOffset, the Incrementaloffset, Lower input valueand Upper input value.
Depress the “CalibrateSystem” button
The “Step1 – Low pressure factor”screen comes on.
Pass
Fail
3Open the valve of thetest device.
Press “Enter”
The P(pv) value is displayed in theappropriate window.
The “Time remaining” counter startscounting down to zero.
Make note of the pressure (pv) valuewhen the counter reaches zero.
When the counter reaches zero the“Step2 – High pressure factor”screen comes on.
Pass
Fail
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 25
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CONFIDENTIALCOMPANY PROPRIETARY
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
4
Close the valve of thetest device.
Adjust the flow rate untilthe Flow(pv) reads 50.
Press “Enter”
The P(pv) value is displayed in theappropriate window.
The “Time remaining” counter startscounting down to zero.
Make note of the pressure (pv) valuewhen the counter reaches zero.
When the counter reaches zero the“Step3 – Calibration confirmation”screen comes on.
Pass
Fail
5
Make note of the FixedOffset, IncrementalOffset Current and Newvalues.
The current values displayed are thesame as the values previouslyrecorded.
Pass
Fail
6 Press the “Accept” buttonPop up window comes on: “You arechanging system calibration. Are yousure”
Pass
Fail
7 Press the “Yes” button. Pop up window comes on:“Calibration has been changed”
Pass
Fail
8 Press “Exit” button The Home screen comes on. Pass
Fail
9 Re-enter the calibrationscreen
The System Calibration screencomes on.
The Fixed Offset, the Incrementaloffset, the Lower input value and theUpper input value match thepreviously recorded values.
Pass
Fail
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 26
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5.12. TEST # 12 – PRINTING FUNCTION - IN–SITU CALIBRATION PARAMETERS
Test Purpose: This test covers the functionality of the calibration parameters printing.
Test Tools: None
Test Set up: None
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1From Home screen,depress the Calibrationbutton
The System Calibration screencomes on.
Pass
Fail
2
Make note of the FixedOffset, the Incrementaloffset, Lower input valueand Upper input value.
Depress the Printer icon
A print out of the calibrationparameters is generated.
The values printed match the valuesdisplayed on the screen.
Pass
Fail
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 27
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5.13. TEST # 13 – PRINTING FUNCTIONS - PARAMETERS
Test Purpose: This test confirms the parameter data printed is complete and accurate
Test Tools: None
Test Set up: None.
Test Set up: None.
StepNo. Test Method Expected Result Actual Result
Pass /Fail
Initials/ Date
Comments /ExceptionReport #
1
Place the key lock in the“unlocked” position
Enter the ParameterManagement screen anddepress the printer icon
A print out comes out
The print out header includes thecorrect date.
The print out lists all parameter IDlabels with the associatedprogrammed values.
Pass
Fail
2
Depress the “Overview”button from theparameters managementscreen.
The parameter list and theassociated values is displayed onthe OIT.
Pass
Fail
3Compare the printedvalues with the OITdisplayed values.
The id labels and associated valuesbetween the printed list and thedisplayed list match.
Pass
Fail
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 28
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6. EXECUTION NOTES
TestNo. Notes
Functional Test Protocol - GIT-LCA Glove Integrity Tester Date: June 8, 2007 Page 29
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7. PROTOCOL COMPLETION STATEMENT/SYSTEM READINESS FOR FAT
All GIT-LCA Glove Integrity Tester functions have been tested per this protocol on ________________ and the system has met all acceptance criteria. Allexception conditions and other issues encountered during the test process have been corrected, as documented in the “notes” section of this document. Thesystem is ready for FAT testing.
Signed:___________________________ Time:__________ Date:____________
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